An investigator from the Food and Drug Administration (FDA) inspected your bakery product manufacturing facility located at Calle Barbosa No. 43, Bayamon, Puerto Rico 00960 on January 24, 25, 26 and February 7 and 9, 2011. Copies of your labeling were collected during the inspection. Review of your labels found your firm's products are not labeled in accordance with FDA's food labeling regulation, 21 CPR Part 101. These violations cause your "Kanelle Bizcocho de Canela y Nueces (Cup Cakes)", "Kanelle Bizcocho de Canela y Nueces (Mini Cakes)," "Kanelle Bizcocho de Canela y Nueces (Mini Chocolate)," and "Kanelle Bizcocho de Canela y Nueces (Loaf Sugar Free)" products to be misbranded in violation of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) and your "Kanelle Bizcocho de Canela y Nueces (Cup Cakes)", "Kanelle Bizcocho de Canela y Nueces (Mini Cakes)," and "Kanelle Bizcocho de Canela y Nueces (Loaf Sugar Free)" products to be adulterated in violation of section 402 of the Act. You can find the Act and the CFR through links on FDA's home page at http://www.fda.gov.

Your significant violations were as follows:

Violations of Food Additive and Color Additive Regulations:

Your "Kanelle Bizcocho de Canela y Nueces (Loaf Sugar Free)" is adulterated within the meaning of section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(2)(C)(i)] in that it bears a food additive that is unsafe within the meaning of section 409(a)(2) of the Act [21 U.S.C. § 348]. Section 409(a)(2) deems a food additive to be unsafe unless its use conforms with a regulation prescribing the conditions of safe use. 21 CFR 172.804(d)(2) states that a condition of safe use for the food additive aspartame is that aspartame containing product labels must bear the statement "PHENYLKETONURICS: CONTAINS PHENYLALANINE." Your "Kanelle Bizcocho de Canela y Nueces (Loaf Sugar Free)" product contains aspartame as a sweetener agent, but the label fails to bear the statement "PHENYLKETONURICS: CONTAINS PHENYLALANINE" on the principal display or information panel.

Your "Kanelle Bizcocho de Canela y Nueces (Cup Cakes)" and "Kanelle Bizcocho de Canela y Nueces (Mini Cakes)" products are adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because the products bear or contain a color additive which is unsafe within the meaning of section 721(a) of the Act [21 U.S.C. § 379(a)]. Section 721(a) deems a color additive to be unsafe unless its use is in conformity with the color additive's listing regulation. Specifically, the listing regulation for FD&C Yellow No. 5 requires that the color additive be listed by that name in the ingredient list on the labels of foods for human use [21 CPR 74.705(d)(2)]. Your "Kanelle Bizcocho de Canela y Nueces (Cup Cakes)" and "Kanelle Bizcocho de Canela y Nueces (Mini Cakes)" products are manufactured with (b)(4) ingredient which contains FD&C Yellow 5; however, the labels for the finished products fail to declare the presence of FD&C Yellow 5 in the ingredient statements.

• In accordance with 21 CFR 101.22(k), the label of a food to which any coloring has been added shall declare the coloring in the statement of ingredients. Your "Kanelle Bizcocho de Canela y Nueces (Cup Cakes)" and "Kanelle Bizcocho de Canela y Nueces (Mini Cakes)" products are manufactured with (b)(4) ingredient containing certified color additives Yellow 5 and Yellow 6; however, the product fails to declare it on the finished product label. Furthermore, your "Kanelle Bizcocho de Canela y Nueces (Mini Chocolate)" product is manufactured with (b)(4) Chocolate Creme Cake base which also contains caramel color, Red 40 and Blue 1, which you failed to declare on the finished product label.

• In accordance with 21 CFR 101.22(h) and 21 CFR 101.22(h)(1), the label of a food to which flavor has been added shall declare the flavor in the statement of ingredients and artificial flavor may be declared as "artificial flavor." The (b)(4) used in your "Kanelle Bizcocho de Canela y Nueces (Cup Cakes)" and "Kanelle Bizcocho de Canela y Nueces (Mini Cakes)" products contain "artificial flavor" which you also fail to declare on the finished product label. Furthermore, your "Kanelle Bizcocho de Canela y Nueces (Mini Chocolate)" product is manufactured with (b)(4)Chocolate Creme Cake base which also contains "artificial flavor," whichyou failed to declare on the finished product label.

2. Your "Kanelle Bizcocho de Canela y Nueces (Loaf Sugar Free)" product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343 (r)(1)(A)] in that the label bears the nutrient content claim "Sugar Free," but fails to meet the requirements to make such a claim [21 CFR 101.60(c)(1)]. The phrase "Sugar Free" meets the definition of a nutrient content claim because it characterizes the product's level of sugar, which is a nutrient of the type required to be in nutrition labeling. To bear a "sugar free" claim, a food must contain less than 0.5 grams of sugar per reference amount customarily consumed (RACC) and per labeled serving. According to your product label, your product contains 19 of sugar per serving which fails to meet the sugar content requirement to make a "Sugar Free" claim.

3. Your "Kanelle Bizcocho de Canela y Nueces (Mini Chocolate)" product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the label fails to declare the major food allergen, soy, as required by section 403(w)(1) of the Act [21 U.S.C. § 343(w)(1)].1 The product is manufactured using "Chocolate Creme Cake Base," which contains soy, but you fail to declare the allergen on the finished product label.

4. Your "Kanelle Bizcocho de Canela y Nueces (Cup Cakes)," "Kanelle Bizcocho de Canela y Nueces (Mini Chocolate)," and "Kanelle Bizcocho de Canela y Nueces (Loaf Sugar Free)" products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4(b)(2).

• All three products contain multi-component ingredients such as sour cream, pudding mix, cake flour, cream frosting and all-purpose white frosting, but fail to list the sub-ingredients. The requirement to list these component ingredients (or "sub-ingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.

• Your "Kanelle Bizcocho de Canela y Nueces (Cup Cakes)" product declares "oil" on the label but fail to list the specific components. Under 21 CFR 101.4(b)(14), each individual fat and or oil ingredient of a food intended for human consumption must be declared by its specific common or usual name (e.g., "beef fat," "cottonseed oil") in its order of predominance in the food except that blends of fats and/or oils may be designated in their order of predominance in the foods as "__ shortening" or "blend of__ oils," the blank to be filled in with the word "vegetable," "animal," "marine," or combination of these, whichever is applicable if, immediately following the term, the common or usual name of each individual vegetable, animal, or marine fat or oil is given in parentheses, e.g., "vegetable oil shortening (soybean and cottonseed oil)."

o The total calorie content is not expressed to the nearest 10-calorie increment [21 CFR 101.9(c)(1)].o The Calories from Fat content is not expressed to the nearest 10-calorie increment for caloric content above 50 and the nearest 5-calories increment for caloric content 50 and below [21 CFR 101.9(c)(1)(ii)].o The Total Fat content is not expressed to the nearest gram for fat content above 5 and the nearest 0.5 gram for fat content 5 and below [21 CFR 101.9(c)(2)].o The Saturated Fat content is not expressed to the nearest 0.5-gram increment [21 CFR 101.9(c)(2)(i)].o The Cholesterol content is not expressed to the nearest 5-milligram increment [21 CFR 101.9(c)(3)].o Some of the Vitamin and Minerals listed are not declared to the nearest 2% increment up to the 10% level and the nearest 5% increment above the 10% up to the 50% level [21 CFR 101.9(c)(8)(iii)].

• For your "Kanelle Bizcocho de Canela y Nueces (Cup Cakes)," "Kanelle Bizcocho de Canela y Nueces (Mini Cakes),"and "Kanelle Bizcocho de Canela y Nueces (Mini Chocolate)" products the serving size declaration are "2" or "2 oz," which are not expressed in common household measure in accordance with 21 CFR 101.9(b)(5) and 21 CFR 101.12(b). For example, a sample serving size statement for your products is "_ piece(s) C g)." For the same three products, the Polyunsaturated Fat content is not expressed to the nearest 0.5-gram increment for content below 5 grams [21 CFR 101.9(c)(2)(iii)] and the Monounsaturated Fat content is not expressed to the nearest 0.5-gram increment [21 CFR 101.9(c)(2)(iv)].

• For your "Kanelle Bizcocho de Canela y Nueces (Loaf Sugar Free)" product, the percent daily value for total carbohydrate is calculated incorrectly. Your label declares a total carbohydrate content of 27.4g and a percent daily value of 18%. Based on a recommended daily value of 300g, your product would contain a percent daily value of approximately 9% [21 CFR 101.9(c)(9)].

6. Your "Kanelle Bizcocho de Canela y Nueces (Cup Cakes)" and "Kanelle Bizcocho de Canela y Nueces (Loaf Sugar Free)" are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] in that the labels fail to bear a statement of the net quantity of content [21 CFR 101.105].

Establishment Registration:

Furthermore, our records indicate that, to date, this facility has not been registered with FDA. Your firm is subject to the registration requirement in Section 415 of the Act [21 U.S.C. § 350d] and our implementing regulation at 21 CFR 1.225 (Subpart H). Be advised that failure to register a facility as required is a prohibited act under Section 301(dd) of the Act [21 U.S.C. § 331(dd)].

As a responsible official of an establishment that manufactures/processes, packs and holds food for human consumption in the United States, you are responsible for ensuring that your overall operations and the products you distribute are in compliance with the law.

We request that you or an individual authorized by this facility's president register the facility with FDA within 30 working days of the date of this letter. Registration may be accomplished on line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.

Alternatively, you or an agent in charge of this facility, or an individual authorized by the facility's president may register the establishment by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or (301) 575-0156, or writing to the agency at the following address:

This letter may not list all the deviations at your establishment. You are reminded that it is your responsibility for ensuring that your firm operates in compliance with the regulations for Food Labeling [21 CFR Part 101] and all other applicable laws and regulations. You should take prompt action to correct these violations and to implement procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice, including seizure and injunction.

In addition to the violations cited above, we also note that there were sanitation issues included in the List of Inspectional Observations provided to your firm and discussed with you during the inspection. You promised to correct these sanitation issues. During out next inspection, the correction of these issues will be investigated and documented.

Also, we note that in addition, your "Kanelle Bizcocho de Canela y Nueces (Cup Cakes)," "Kanelle Bizcocho de Canela y Nueces (Mini Cakes)," "Kanelle Bizcocho de Canela y Nueces (Mini Chocolate)," and "Kanelle Bizcocho de Canela y Nueces (Loaf Sugar Free)" products are labeled to contain the ingredient "nuts" but fail to declare the type of nut, i.e., walnuts, on their labels as specified in section 403(w)(2) of the Act.

And we note that your "Kanelle Bizcocho de Canela y Nueces (Loaf Sugar Free)" product bears the claim "No Sugar Added," but fails to meet the requirements for such a claim. To make this claim, unless the food meets the requirements for "low calorie" or "reduced calorie," as defined in 21 CFR 101.60(b)(2) or 21 CFR 101.60(b)(4), the product label must also bear the statement that the product is not "low calorie" or "reduced calorie" and refer the consumer to the nutrition information for the sugar and calorie content [21 CFR 101.60(c)(2)(v)]. Your product label does not bear the additional statements required to bear the claim "No Sugar Added."

Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations cited above. You should include in your response documentation such as documents and/or procedures implemented, copies of the revised labels for the products that your firm manufactures and distributes, or other information that would assist us in evaluating your corrections. If you can not complete all corrections before you respond, this agency expects that you will explain the reason for your delay and state when you will correct any remaining violations.

Your written reply to these concerns should be directed to the Food and Drug Administration, attention: Rafael Nevarez, Compliance Officer, at 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding any issue in this letter, please contact Mr. Nevarez at (787) 474-9545.

Sincerely, /S/Maridalia TorresDistrict DirectorSan Juan District

1 Section 201(qq) of the Act [21 U.S.C. § 321(qq)] defines "major food allergens" as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either: the word "Contains" followed by the name of the food source from which the major food allergen is derived is printed immediately after or adjacent to the list of ingredient [section 403(w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1)(A)], or the common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., "flour (wheat)"), except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) [section 403(w)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B)].